Survey
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
* Your assessment is very important for improving the workof artificial intelligence, which forms the content of this project
Lutembacher's syndrome wikipedia , lookup
Arrhythmogenic right ventricular dysplasia wikipedia , lookup
Jatene procedure wikipedia , lookup
Dextro-Transposition of the great arteries wikipedia , lookup
History of invasive and interventional cardiology wikipedia , lookup
CARE AND MAINTENANCE The care and and maintenance of the catheter requires well trained, skilled personnel following a detailed protocol. The protocol should include a directive that the catheter is not to be used for any purpose other than the prescribed therapy. Accessing Catheter, Cap Changes, Dressing Changes6 • Experienced personnel • Use aseptic technique • Proper hand hygiene • Clean gloves to access catheter and remove dressing and sterile gloves for dressing changes • Surgical mask (1 for the patient and 1 for the healthcare professional) • Catheter exit site should be examined for signs of infection and dressings should be changed at each dialysis treatment. • Catheter Luer-lock connectors with end caps attached should be soaked for 3 to 5 minutes in povidone iodine and then allowed to dry before separation. • Carefully remove the dressing and inspect the exit site for inflammation, swelling and tenderness. Notify physician immediately if signs of infection are present. Exit Site Cleaning11 • Use aseptic technique (as outlined above). • Clean the exit site at each dialysis treatment with chlorhexidine gluconate unless contraindicated. Apply antiseptic per manufacturer’s recommendations. Allow to air dry completely. • Cover the exit site with sterile, transparent, semipermeable dressing or per hospital protocol. The Equistream* and Equistream* XK catheters have two separate free floating tips, separated at a fixed point. Recommended Cleaning Solutions Catheter Luer-lock Connectors/End Caps: • Povidone iodine (allow connectors/end caps to soak for 3 to 5 minutes) 8 WARNING: Alcohol should not be used to lock, soak or declot polyurethane Dialysis Catheters because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure. Hand cleaner solutions are not intended to be used for disinfecting our dialysis catheter Luer-lock connectors. Exit Site: • Chlorhexidine gluconate 2% solution (preferred) 6, 10, 11, 12, 13 • Chlorhexidine gluconate 4% solution • Dilute aqueous sodium hypochlorite • 0.55% sodium hypochlorite solution • Povidone iodine • Hydrogen peroxide • Chlorhexidine patches • Bacitracin zinc ointments in petrolatum bases WARNING: Acetone and PEG-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments (e.g., Polysporin* ointment) are the preferred alternative. INSTRUCTIONS FOR USE For Equistream* Straight and Alphacurve* Configuration Catheters ___________________________________________________________________________________________________________ DESCRIPTION The Equistream* and Equistream* XK catheters are made of radiopaque polyurethane, and allow for flow rates as high as 500 ml/min. The catheter shaft is divided internally into two separate lumens by a septum allowing hemodialysis without the use of a “single needle” system. The catheter comes with a white retention cuff for tissue ingrowth to anchor the catheter. INDICATIONS FOR USE The Equistream* and Equistream* XK long-term hemodialysis catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion. CONTRAINDICATION This device is contraindicated for patients exhibiting severe, uncontrolled thrombocytopenia or coagulopathy. WARNINGS Subclavian Vein CATHETER REMOVAL Evaluate the catheter routinely and promptly remove any nonessential catheter11 per physician’s orders. The white retention cuff facilitates tissue in-growth. The catheter must be surgically removed. Free the cuff from the tissue and pull the catheter gently and smoothly. After removing the catheter, apply manual pressure to the puncture site for 10-15 minutes until no signs of bleeding are present. Then apply sterile, transparent, semipermeable dressing or dressing per hospital protocol for a minimum of 8 hours. Follow hospital protocol regarding bedrest after catheter removal. DISPOSAL After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and all applicable local, state and federal laws and regulations. TROUBLESHOOTING PATIENT WITH FEVER Patient with fever and chills following the procedure may be indicative of catheter-related bacteremia. If bacteremia is present, removal of the catheter may be indicated. INSUFFICIENT FLOW Excessive force must not be used to flush an obstructed lumen. Insufficient blood flow may be caused by an occluded tip resulting from a clot or by contacting the wall of the vein. If manipulation of the catheter or reversing arterial and venous lines does not help, then the physician may attempt to dissolve the clot with a thrombolytic agent (e.g., TPA, Cathflo* Activase* thrombolytic). Physician discretion advised. CATHETER EXCHANGE Do not routinely replace dialysis catheters to prevent catheter-related infections13. It may become necessary to exchange the indwelling catheter due to a persistent rise in pressures or decrease of flow rates which cannot be rectified through troubleshooting. Catheter exchanges should be performed under strict aseptic conditions in which the physician should wear a cap, mask, sterile gown, sterile gloves, and use a large sterile drape to cover the patient. REFERENCES: Aitken, D.R. and Minton, J.P. “The Pinch-Off Sign: A Warning of Impending Problems with Permanent Subclavian Catheters”, American Journal of Surgery, Vol. 148, Nov. 1984, pp.633-638. Patel, A, et al “Sheathless Technique of Ash Split Catheter Insertion.” J Vasc Interv Radiol 2001; 12:376-378. 3 Zaleski, GX, et al. “Experience with Tunneled Femoral Hemodialysis Catheters.” Am J Roentgenol. 1999 Feb; 172(2):493-6. 4 Rogers, P.R. et al “Pocket Radiologist Interventional Top 100 Procedures”, Amirsys, 1st Ed., 2003. 5 Mickley, V., “Central venous catheters: many questions: few answers”, Nephrol Dial Transplant, (2002) 17:1368-1373. 6 National Kidney Foundation K/DOQI Guidelines, 2006. 7 Sulek, CA., Blas, ML., Lobato, EB, “A randomized study of left versus right internal jugular vein cannulation in adults.” J Clin Anesth. 2000 Mar;12(2):142-5 8 Tan, P.L., Gibson, M., “Central Venous Catheters: the role of radiology”, Clin Rad. 2006, 61:13-22 9 Octavio, Bella, Colemenares, Garcia, and Flores; “Right Verses Left Internal Vein Catheterization for Hemodialysis: Complications and Impact on Ipsilateral Access Creation”; Artifical Organs; 2004, 28(8):728-733. 10 The Institute for Healthcare Improvement, “How-to-Guide: Prevent Central Line Infections,” 2006. 11 The Joint Commission Hospital Accreditation Organization, National Patient Safety Goals, 2009. 12 Center for Disease Control and Prevention, “Guidelines for the Prevention of Intravascular Catheter-Related Infections,” Morbidity and Mortality Weekly Report, Aug. 9, 2002, 51(RR-10), 1-32. 13 The Society for Healthcare Epidemiology of America, “Strategies to Prevent Central Line-Associated Bloodstream Infections in Acute Care Hospitals,” Infection Control and Hospital Epidemiology, Oct. 2008, 29(S1): S22-S30. 1 2 Other references available upon request. ___________________________________________________________________________________________________________ An issued or revision date for these instructions is included for the users information. In the event two years have elapsed between this date and product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available. Revision date: October, 2010. *Bard, Alphacurve, Equistream, and StatLock are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © 2010 C. R. Bard, Inc. All rights reserved. 0727467 1011R Bard Access Systems, Inc. Salt Lake City, UT 84116 U.S.A. 1-801-522-5000 Customer Service: 800-545-0890 Clinical Information: 800-443-3385 www.bardaccess.com Vertebra Internal Jugular Vein Superior Vena Cava Clavicle Axillary Vein POST DIALYSIS Use aseptic technique (as outlined above). 1. Flush arterial and venous lumens with a minimum of 10 mL of sterile saline. WARNING: To avoid damage to vessels and viscus, infusion pressures must not exceed 25 psi (172 kPa). The use of a 10 mL or larger syringe is recommended because smaller syringes generate more pressure than larger syringes. 2. Inject heparin solution into both the arterial and venous lumens of the catheter. The appropriate heparin solution concentration and flushing frequency should be based on hospital protocol. Heparin solution of 1,000 to 5,000 units/mL has been found to be effective for maintaining the patency of hemodialysis and apheresis catheters. When injecting heparin solution, inject quickly and clamp extension while under positive pressure. Heparin solution volume to lock each lumen must be equal to the priming volume of each lumen. Priming volumes are marked on each lumen. 3. Clean catheter Luer-lock connectors per hospital protocol. Attach sterile end caps to both the arterial and the venous clamping extension pieces. WARNING: To prevent systemic heparinization of the patient, the heparin solution must be aspirated out of both lumens immediately prior to using the catheter. In most instances, no further heparin solution injection is necessary for 48-72 hours, provided the catheter has not been aspirated or flushed. First Rib Pinch-off Area Sternum Infraclavicular Fossa WARNING: Percutaneous insertion of the catheter should be made into the axillary-subclavian vein at the junction of the outer and mid-thirds of the clavicle lateral to the thoracic outlet. The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and clavicle and can lead to damage or fracture and embolization of the catheter.1 Fluoroscopic or radiographic confirmation of catheter tip placement should be helpful in demonstrating that the catheter is not being pinched by the first rib and clavicle.1 • Alcohol or alcohol-containing antiseptics (such as chlorhexidine) may be used to clean the catheter/skin site; however, care should be taken to avoid prolonged or excessive contact with the solution(s). Solutions should be allowed to completely dry before applying dressing. • Acetone and Polyethylene Glycol (PEG)-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments (e.g., Polysporin* ointment) are the preferred alternative. • Follow Universal Precautions when inserting and maintaining this device. • Cardiac arrhythmias may result if the guidewire and/or stylet touches the walls of the right atrium. Use cardiac rhythm monitoring to detect arrhythmias. • Close all clamps only in the center of the extension legs. Extensions may develop cuts or tears if subjected to excessive pulling or contact with rough edges. Repeated clamping near or on the Luer-lock connectors may cause tubing fatigue and possible disconnection. • Catheters should be implanted carefully. • Any sharp or acute angles that could compromise the opening of the catheter lumens need to be avoided. • To prevent air embolism and/or blood loss put patient in Trendelenburg position and always place thumb over the exposed orifice of the sheath introducer. • To avoid damage to vessels and viscus, infusion pressures should not exceed 25 psi (172 kPa). The use of a 10 mL or larger syringe is recommended because smaller syringes generate more pressure than larger syringes. Note: A three pound (13.3 Newton) force on the plunger of a 3 mL syringe generates pressure in excess of 30 psi (206 kPa) whereas the same three pound (13.3 Newton) force on the plunger of a 10 mL syringe generates less than 15 psi (103 kPa) of pressure. • Accessories and components used in conjunction with this catheter should incorporate Luer-lock adapters. • The heparin solution must be aspirated out of both lumens immediately prior to using the catheter to prevent systemic heparinization of the patient. • Failure to clamp extensions when not in use may lead to air embolism. • In the rare event of a leak, the catheter should be clamped immediately. Necessary remedial action must be taken prior to resuming dialysis or infusion procedure. • The risk of infection is increased with femoral vein insertion. • Do not resterilize the catheter or components by any method. The manufacturer will not be liable for any damages caused by reuse of the catheter or accessories. • Cannulation of the left internal jugular vein was reportedly associated with a higher incidence of complications compared to catheter placement in the right internal jugular vein.7 • Alcohol should not be used to lock, soak or declot polyurethane Dialysis Catheters because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure. • Intended for Single Use. DO NOT REUSE. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. CAUTIONS • Repeated over tightening of blood lines, syringes and caps will reduce connector life and could lead to potential connector failure. In case of damage, clamp the catheter between the patient and the damaged area with a smooth-edged, atraumatic clamp. • Sterile and non-pyrogenic only if packaging is not opened, damaged or broken. • Read the instructions for use carefully before using this device. • CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. • Left sided placement in particular, may provide unique challenges due to the right angles formed by the innominate vein and at the left brachiocephalic junction with the SVC.5,8 • Care should be taken NOT to force the dilator sheath introducer assembly into the vessel during insertion as vessel damage including perforation could result. • Stylet is intended for use over a guidewire to aid in placement. Inserting the stylet into the venotomy without tracking over a guidewire could result in vessel damage including perforation. • Failure to retract the stylet when inserting the tunneler into the catheter tip can result in damage to the stylet. • Ensure that the catheter does not move out of the vein while removing the insertion stylet. • Care should be taken not to advance the split sheath too far into vessel as a potential kink would create an impasse to the catheter. • Ensure that the introducer sheath is only torn externally. Catheter may need to be further pushed into the vessel as sheath is torn. • For optimal product performance, do not insert any portion of the cuff into the vein. • If the microintroducer guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire. • Before attempting the insertion of Equistream* catheters, ensure that you are familiar with the complications listed below and their emergency treatment should any of them occur. • The complications listed below as well as other complications are well documented in medical literature and should be carefully considered before placing the catheter. Placement and care of Equistream* catheters should be performed by persons knowledgeable of the risks involved and qualified in the procedures. POSSIBLE COMPLICATIONS The use of an indwelling central venous catheter provides an important means of venous access for critically ill patients; however, the potential exists for serious complications including the following: •Air Embolism •Arterial Puncture •Bleeding •Brachial Plexus Injury •Cardiac Arrhythmia •Cardiac Tamponade •Catheter or Cuff Erosion Through the Skin •Catheter Embolism •Catheter Occlusion •Catheter Occlusion, Damage or Breakage due to Compression Between the Clavicle and First Rib1 • Catheter-related Sepsis •Endocarditis •Exit Site Infection •Exit Site Necrosis •Extravasation •Fibrin Sheath Formation •Hematoma •Hemomediastinum •Hemothorax •Hydrothorax •Inflammation, Necrosis or scarring of skin over implant area •Intolerance Reaction to Implanted Device •Laceration of Vessels or Viscus •Perforation of Vessels or Viscus • Pneumothorax •Thoracic Duct Injury •Thromboembolism •Venous Stenosis •Venous Thrombosis •Ventricular Thrombosis •Vessel Erosion •Risks Normally Associated with Local and General Anesthesia, Surgery, and Post-Operative Recovery INSERTION TECHNIQUE (1) Percutaneous Placement Procedure of the Equistream* catheter with cuff using the Bard Access Systems, Inc. split sheath introducer: Forpercutaneousplacement,thecatheterisinsertedineitherthesubclavianveinorinternaljugularveinthroughasplit sheathintroducer.Ithasbeenreportedthatrightside,internaljugularplacementisthepreferredinitiallocationofconsideration for percutaneous insertion.6,9 The patient should be placed in Trendelenburg position with the head turned to the opposite side of the entry site. A (COMMON STEPS). CATHETERS MUST BE INSERTED UNDER STRICT ASEPTIC CONDITIONS. WARNING:Cannulationoftheleftinternaljugularveinwasreportedlyassociatedwithahigherincidenceofcomplications comparedtocatheterplacementintherightinternaljugularvein.7 CAUTION:Asreportedinliterature,leftsidedcatheterplacementmayprovideuniquechallengesduetotherightangles formedbytheinnominateveinandattheleftbrachiocephalicjunctionwiththeSVC.5,8 1. Provideasterilefieldthroughouttheprocedure.Theoperatorshouldwearacap,mask,sterilegown,sterilegloves,andusea large sterile drape to cover the patient. 2. Preparetheaccesssiteusingstandardsurgicaltechniqueanddrapethepreppedareawithsteriletowels.Ifhairremovalis necessary,useclippersordepilatories.Next,scrubtheentireareapreferablywithchlorhexidinegluconateunlesscontraindicated inwhichcasepovidone-iodinesolutionmaybeused.Useaback-and-forthfrictionscrubforatleast30seconds10. Do not wipe or blot.Allowantisepticsolutiontoairdrycompletelybeforepuncturingthesite. 3. (Ifapplicable)Administerlocalanaesthesiatotheinsertionsiteandthepathforsubcutaneoustunnel. 4. Flusheachlumenwithheparinsolutionpriortoinsertionandclamptheextensionlegs.Ifusingstylet,do not clamp the arterial (red)lumenuntilthearterialinsertionstyletandguidewireareremoved.Clampingwillkinkthestyletandpreventguidewire passage. 5. Inserttheintroducerneedlewithanattachedsyringetothedesiredlocation.Aspirategentlyastheinsertionismade. 6. When the vein has been entered, remove the syringe leaving the needle in place. 7. Ifusingamicropunctureset,inserttheflexibleendofthemicrointroducerguidewireintotheneedle.Advancethemicrointroducer guidewireasfarasappropriate.Verifycorrectpositioning,usingfluoroscopyorultrasound. • Gentlywithdrawandremovetheneedle,whileholdingtheguidewireinposition. CAUTION:Ifthemicrointroducerguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwire as a unit to prevent the needle from damaging or shearing the guidewire. • Advancethesmallsheathanddilatortogetherasaunitoverthemicrointroducerguidewire,usingaslightrotationalmotion. Advancetheunitintotheveinasfarasappropriate. • Withdrawthedilatorandmicrointroducerguidewire,leavingthesmallsheathinplace. WARNING:Placeathumbovertheorificeofthesheathtominimizebloodlossandriskofairaspiration. 8. Thestandardguidewirecanbeinsertedintotheneedlehubandpassedthroughtheneedle.Advancethestandardguidewireto the desired location in the vessel. 9. Ifusingamicrointroducer,gentlywithdrawandremovethesmallsheath,whileholdingthestandardguidewireinposition. 10. Removetheneedlewhileholdingtheguidewireinplace.Wipetheguidewirecleanandsecureitinplace. CAUTION: Do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire. The introducer needlemustberemovedfirst. 11. Makeasmallincisionattheinsertionsite.Makeasecondincisionatthedesiredexitsiteofthecatheter. 12. B(CommonSteps). Step1. 1. 2. 3. 4. GotoA(CommonSteps). SkipB(CommonSteps). SkipC(InsertionTechnique(1)PercutaneousPlacement). Locatethedesiredvesselforinsertionofthecatheterwithasmallincision.NOTE:Ifperformingajugularinsertionandexternal veinisnotofadequatesizetoaccommodatethecatheter,theinternalveinmaybeused.Apursestringsuturemaybeusedto secure catheter in the internal vein. 5. Makeasmallincisionatthedesiredexitsiteofthecatheter,intheareabetweenthenippleandrightsternalborder.Makethe incisionjustlargeenoughtoaccommodatetheimplantablecuff. 6. GotoB(CommonSteps). 7. Ifnotusingastylet,theproximalendoftheguidewiremustbeinsertedintothesmallvenousendholeofthedistal-mosttip,and threadedintotheendholeofthearterialtip,passingthroughthearteriallumenuntilitextendsoutthearterialLuer-lockconnector (red).Ifusingstylet,threadtheproximalendoftheguidewirethroughthedistaltipofthestyletuntiltheguidewireextendsoutthe styletLuer-lockconnector. 8. Insertthecatheterthroughasmallvenotomyintheselectedvein.Advancethecathetertip.Cathetertipplacement,tiporientation andproperlengthselectionislefttothediscretionofthephysician.However,routinex-rayshouldalwaysfollowtheinitialinsertion toconfirmproperplacementofthecathetertipspriortouse.Therecommendedtiplocationisatthejunctionofthesuperiorvena cava/rightatrium(SVC/RA)orinthemidrightatrium.6Alltipplacementsshouldbeconfirmedbyfluoroscopy. CAUTION:Foroptimalproductperformance,donotinsertanyportionofthecuffintothevein. WARNING:Cardiacarrhythmiasmayresultiftheguidewireand/orstyletisallowedtotouchthewallsoftherightatrium. 9. Removetheguidewireandstyletwhileapplyingforwardpressureonthecathetersoitdoesnotwithdraw. CAUTION:Ensurethatthecatheterdoesnotmoveoutoftheveinwhileremovingtheinsertionstylet. 10. GotoD(CommonSteps) INSERTION TECHNIQUE (3) Sheathless Procedure2: Forsheathlessplacement,thecatheterispreferablyinsertedintotheinternaljugularvein.Forthesheathlessprocedure,thepatient should be placed in Trendelenburg position with the head turned to the opposite side of the entry site. 5. 6. Step2. 7. 8. Step3. C (INSERTION TECHNIQUE (1): PERCUTANEOUS PLACEMENT) 1. Unlock,remove,anddiscardstylet. CAUTION:Styletisintendedforuseoveraguidewiretoaidinplacement.Insertingthestyletintothevenotomywithouttracking over a guidewire could result in vessel damage including perforation. 2. Fillthecatheterlumenswithheparinizedsalinesolution. 3. Advancethedilatorsheathintroducerassemblyovertheexposedguidewireintothevessel. CAUTION:CareshouldbetakenNOTtoforcethedilatorsheathintroducerassemblyintothevesselduringinsertionasvessel damageincludingperforationcouldresult.Asreportedinliterature,leftsidedcatheterplacementmayprovideuniquechallenges duetotherightanglesformedbytheinnominateveinandattheleftbrachiocephalicjunctionwiththeSVC.5,8 WARNING:Cardiacarrhythmiasmayresultiftheguidewireisallowedtotouchthewallsoftherightatrium. 4. Withdrawthevesseldilatorandguidewire,leavingtheintroducersheathinplace. CAUTION:Careshouldbetakennottoadvancethesplitsheathtoofarintovesselasapotentialkinkwouldcreateanimpasseto the catheter. WARNING:Topreventairembolismand/orbloodloss,placethumbovertheexposedorificeofthesheathintroducer. 5. Removethumbandfeeddistalsectionofcatheterintothesheathintroducer.Advancethecathetertip.Cathetertipplacement,tip orientationandproperlengthselectionislefttothediscretionofthephysician.However,routinex-rayshouldalwaysfollowthe initialinsertiontoconfirmproperplacementofthecathetertipspriortouse.Therecommendedtiplocationisatthejunctionofthe superiorvenacava/rightatrium(SVC/RA)orinthemidrightatrium.6Alltipplacementsshouldbeconfirmedbyfluoroscopy. 6. Withthecatheteradvanced,peelawaythesheathbygrippingthe“T”handleandbreakingitapartwithadownwardandoutward motion to initiate separation and withdrawal of the sheath. CAUTION:Ensurethattheintroducersheathisonlytornexternally.Cathetermayneedtobefurtherpushedintothevesselas sheath is torn. CAUTION:Foroptimalproductperformance,donotinsertanyportionofthecuffintothevein. 7. D(CommonSteps). D (COMMON STEPS) 1. Confirmcatheterpatencybyreleasingclampandaspiratingbloodthrougheachlumen. 2. Flusheachlumenwith10mLsterilesalineusinga10mLorlargersyringe. WARNING:Toavoiddamagetovesselsandviscus,infusionpressuresshouldnotexceed25psi(172kPa).Theuseofa10mLor larger syringe is recommended because smaller syringes generate more pressure than larger syringes 3. Injectheparinsolutionintoeachlumeninamountsequaltotheprimingvolumesasprintedonthecatheterclamps.Besureto clamp each lumen immediately. WARNING:Failuretoclampextensionswhennotinusemayleadtoairembolism. 4. Foradditionalsecurity,suturetheentireentrysite,oruseaStatlock*CatheterStabilizationdevicetoanchorthecatheter. 5. Followyourhospitalprotocolfordressingchangeandexitsitecare.Allowalcohol-containingagents(e.g.,Chloraprep*solution)to air dry completely before dressing catheter. WARNING:AcetoneandPEG-containingointmentscancausefailureofthisdeviceandshouldnotbeusedwithpolyurethane catheters.Chlorhexidinepatchesorbacitracinzincointments(e.g.,Polysporin*ointment)arethepreferredalternative. 6. Verifythecathetertiplocationwithx-rayorfluoroscopy. 9. 10. GotoA(CommonSteps). GotoB(CommonSteps). SkipC(InsertionTechnique(1)PercutaneousPlacement). Sequentiallydilate(guidingdilatorsovertheguidewire),thevenouspuncturesitetoaccommodatethecatheter(dilatevesseltoat leastthesameFrenchsizeasthecatheter,andpreferablyto1.5Flarger). Afterremovingthedilator,keeptheguidewireinthevenoussystemwhileapplyingdigitalcompressionatthepuncturesiteto maintain hemostasis. Ifnotusingastylet,theproximalendoftheguidewiremustbeinsertedintothesmallvenousendholeof 6. thedistal-mosttip,andthreadedintotheendholeofthearterialtip,passingthroughthearteriallumenuntil itextendsoutthearterialLuer-lockconnector(red).Ifusingstylet,threadtheproximalendoftheguidewire throughthedistaltipofthestyletuntiltheguidewireextendsoutthestyletLuer-lockconnector. Tominimizetheriskofairembolism,clampthevenousextensionleg(indicatedbytheblueLuer-lock connector). Advancethecatheteroverthewire,untilthetipreachesthedesiredlocation.Notethatsomeresistancemaybeexperiencedwhen passing the catheter through the soft tissues, but this should subside once the catheter tip is intravascular. CAUTION:Foroptimalproductperformance,donotinsertanyportionofthecuffintothevein. WARNING:Cardiacarrhythmiasmayresultiftheguidewireand/orstyletisallowedtotouchthewallsoftherightatrium. Removetheguidewireandstylet(ifapplicable)whileapplyingforwardpressureonthecathetersoitdoesnotwithdraw. CAUTION:Ensurethatthecatheterdoesnotmoveoutoftheveinwhileremovingtheinsertionstylet. GotoD(CommonSteps). INSERTION TECHNIQUE (4) Femoral Vein Placement Procedure: Forfemoralplacement,thepatientshouldbepositionedsupine,andthecathetertipshouldbeinsertedtothejunctionoftheiliacvein and inferior vena cava3. WARNING: The risk of infection is increased with femoral vein insertion. Note:Cathetersgreaterthan40cmareintendedforfemoralveininsertion. 1. Assesstherightandleftfemoralareasforsuitabilityforcatheterplacement.Ultrasoundmaybehelpful. 2. Onthesamesideastheinsertionsite,thepatient’skneeshouldbeflexed,andthethighabductedwiththefootplacedacrossthe opposing leg. 3. Locatethefemoralvein,posterior/medialtothefemoralartery. 4. GotoA(CommonSteps). 5. GotoB(CommonSteps),directingtunnellaterallytodecreasetheriskofinfection.4 6. GotoC(InsertionTechnique(1)PercutaneousPlacement). 14.5 F Equistream* Catheter Venous and Arterial Pressures • 250 19 cm Venous 150 Optional:Placeapre-cutgauzedressingover theexitsite,fittingitsnuglyaroundthecatheter. Placea2in.x2in.(5cmx5cm)gauzeover thepre-cutgauzeandcatheter. 2. Applyacoverdressing,leavingtheextension legsexposed.Ifusingasterile,transparent, semipermeable dressing, the following is recommended: 19 cm Arterial 42 cm Arterial 100 50 0 300 mL/min 350 mL/min 400 mL/min 450 mL/min 500 mL/min -50 • As suggested by in vitro data, using a blood simulate approximating the viscosity of whole blood. Reverse Flow Rate vs Venous Pressures • -100 42 cm Straight Catheter Reverse Flow -150 300 mL/min 400 mL/min -200 140 mmHg 159 mmHg -250 16 F Equistream* XK Catheter Venous and Arterial Pressures • 250 42 cm Venous 200 2b.Viewingcathetersitethroughthedressingon theskinsothattheslitisoverthecatheterhub.Pressone side of dressing into place while holding the other side off the skin. 2c. Partiallyremovetheframeportionofthe dressing near the catheter hub which is already secured to the skin. 19 cm Venous 150 2a.Cuta1-2inch(3-5cm)slitintheshortside ofthedressingusingsterilescissors.Remove the backing sheet. 19 cm Arterial 42 cm Arterial 100 Pressures (mmHg) 42 cm Venous 200 Recommended Dressing Technique 1. Securethecathetertotheskinusingoneor two sterile tape strips. WARNING: Acetone and PEG-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments (e.g., Polysporin* ointment) are the preferred alternative. INSERTION TECHNIQUE (2) Surgical Cutdown Procedure: Thecathetermaybeinsertedintothesuperiorvenacavaviathesubclavianvein,externaljugularveinortheinternaljugularvein (standardoperatingroomprocedure).Forsurgicalcutdownprocedure,thepatientshouldbeplacedinTrendelenburgpositionwiththe head turned to the opposite side of the entry site. 1. 2. 3. 4. B (COMMON STEPS) 1. Ifusingstylet,unscrewthestylethubfromthearterialLuer-lockconnectorandretractstyletuntilitisno longer visible at the arterial lumen tip. CAUTION:Failuretoretractthestyletwheninsertingthetunnelerintothecathetertipcanresultindamage to the stylet. 2. Withatunneler,createasubcutaneoustunnelfromthecatheterexitsitetoemergeatthevenousentrysite. IfusingtheBard Access Systems, Inc.tunneler(seesteps1to3),attachthecathetertothetunnelerso thatthecatheter’svenoustipslidesoverthebarbedconnectionandrestsadjacenttothesheathstop.This allowsthecathetertobethreadedthroughthetissueasthetunneliscreated.Slidethesheathfoundonthe tunneleroverthevenoustip/tunnelerconnectionuntilitstops.Inaddition,ensuretheopenendofsheathis covering the arterial tip. This will reduce the drag on the arterial tip in the skin tunnel and secure the catheter tothetunneler.(Afterpositioningcuff,tunnelercanberemovedbyslidingsheathawayfromthecatheterand pullingtunnelerfromvenoustip.)Thecathetershouldnotbeforcedthroughthetunnel. 3. Positionthewhiteretentioncuffapproximatelymidwaybetweentheskinexitsiteandthevenousentrysite, 3cmminimum,fromthevenousentrysite.Detachtunnelerfromcatheter. 4. Ifusingstylet,pushthestyletbackintocatheterandtightenstylethubontoarterialcatheterLuer-lock connector.Threadstylettipintoproximalsideofthevenousendholeandallowstylettiptoprotrudefromtip of catheter. 2d.Overlaptheunsecuredsideofthedressing slightly over the secured side to seal dressing undercatheterhub.Carefullyremovethe framefromthedressingwhilefirmly smoothingdowntheedges.Smoothdownthe entire dressing. Pressures (mmHg) 50 0 -50 -100 -150 -200 -250 300 mL/min 350 mL/min 400 mL/min 450 mL/min 500 mL/min • As suggested by in vitro data, using a blood simulate approximating the viscosity of whole blood. Reverse Flow Rate vs Venous Pressures • 42 cm Straight Catheter - Reverse Flow 300 mL/min 97 mmHg 500 mL/min 117 mmHg Forpercutaneousplacement,thecatheterisinsertedineitherthesubclavianveinorinternaljugularveinthroughasplit sheathintroducer.Ithasbeenreportedthatrightside,internaljugularplacementisthepreferredinitiallocationofconsideration for percutaneous insertion.6,9 The patient should be placed in Trendelenburg position with the head turned to the opposite side of the entry site. A (COMMON STEPS). CATHETERS MUST BE INSERTED UNDER STRICT ASEPTIC CONDITIONS. WARNING:Cannulationoftheleftinternaljugularveinwasreportedlyassociatedwithahigherincidenceofcomplications comparedtocatheterplacementintherightinternaljugularvein.7 CAUTION:Asreportedinliterature,leftsidedcatheterplacementmayprovideuniquechallengesduetotherightangles formedbytheinnominateveinandattheleftbrachiocephalicjunctionwiththeSVC.5,8 1. Provideasterilefieldthroughouttheprocedure.Theoperatorshouldwearacap,mask,sterilegown,sterilegloves,andusea large sterile drape to cover the patient. 2. Preparetheaccesssiteusingstandardsurgicaltechniqueanddrapethepreppedareawithsteriletowels.Ifhairremovalis necessary,useclippersordepilatories.Next,scrubtheentireareapreferablywithchlorhexidinegluconateunlesscontraindicated inwhichcasepovidone-iodinesolutionmaybeused.Useaback-and-forthfrictionscrubforatleast30seconds10. Do not wipe or blot.Allowantisepticsolutiontoairdrycompletelybeforepuncturingthesite. 3. (Ifapplicable)Administerlocalanaesthesiatotheinsertionsiteandthepathforsubcutaneoustunnel. 4. Flusheachlumenwithheparinsolutionpriortoinsertionandclamptheextensionlegs.Ifusingstylet,do not clamp the arterial (red)lumenuntilthearterialinsertionstyletandguidewireareremoved.Clampingwillkinkthestyletandpreventguidewire passage. 5. Inserttheintroducerneedlewithanattachedsyringetothedesiredlocation.Aspirategentlyastheinsertionismade. 6. When the vein has been entered, remove the syringe leaving the needle in place. 7. Ifusingamicropunctureset,inserttheflexibleendofthemicrointroducerguidewireintotheneedle.Advancethemicrointroducer guidewireasfarasappropriate.Verifycorrectpositioning,usingfluoroscopyorultrasound. • Gentlywithdrawandremovetheneedle,whileholdingtheguidewireinposition. CAUTION:Ifthemicrointroducerguidewiremustbewithdrawnwhiletheneedleisinserted,removeboththeneedleandwire as a unit to prevent the needle from damaging or shearing the guidewire. • Advancethesmallsheathanddilatortogetherasaunitoverthemicrointroducerguidewire,usingaslightrotationalmotion. Advancetheunitintotheveinasfarasappropriate. • Withdrawthedilatorandmicrointroducerguidewire,leavingthesmallsheathinplace. WARNING:Placeathumbovertheorificeofthesheathtominimizebloodlossandriskofairaspiration. 8. Thestandardguidewirecanbeinsertedintotheneedlehubandpassedthroughtheneedle.Advancethestandardguidewireto the desired location in the vessel. 9. Ifusingamicrointroducer,gentlywithdrawandremovethesmallsheath,whileholdingthestandardguidewireinposition. 10. Removetheneedlewhileholdingtheguidewireinplace.Wipetheguidewirecleanandsecureitinplace. CAUTION: Do not pull back standard guidewire over needle bevel as this could sever the end of the guidewire. The introducer needlemustberemovedfirst. 11. Makeasmallincisionattheinsertionsite.Makeasecondincisionatthedesiredexitsiteofthecatheter. 12. B(CommonSteps). Step1. 1. 2. 3. 4. GotoA(CommonSteps). SkipB(CommonSteps). SkipC(InsertionTechnique(1)PercutaneousPlacement). Locatethedesiredvesselforinsertionofthecatheterwithasmallincision.NOTE:Ifperformingajugularinsertionandexternal veinisnotofadequatesizetoaccommodatethecatheter,theinternalveinmaybeused.Apursestringsuturemaybeusedto secure catheter in the internal vein. 5. Makeasmallincisionatthedesiredexitsiteofthecatheter,intheareabetweenthenippleandrightsternalborder.Makethe incisionjustlargeenoughtoaccommodatetheimplantablecuff. 6. GotoB(CommonSteps). 7. Ifnotusingastylet,theproximalendoftheguidewiremustbeinsertedintothesmallvenousendholeofthedistal-mosttip,and threadedintotheendholeofthearterialtip,passingthroughthearteriallumenuntilitextendsoutthearterialLuer-lockconnector (red).Ifusingstylet,threadtheproximalendoftheguidewirethroughthedistaltipofthestyletuntiltheguidewireextendsoutthe styletLuer-lockconnector. 8. Insertthecatheterthroughasmallvenotomyintheselectedvein.Advancethecathetertip.Cathetertipplacement,tiporientation andproperlengthselectionislefttothediscretionofthephysician.However,routinex-rayshouldalwaysfollowtheinitialinsertion toconfirmproperplacementofthecathetertipspriortouse.Therecommendedtiplocationisatthejunctionofthesuperiorvena cava/rightatrium(SVC/RA)orinthemidrightatrium.6Alltipplacementsshouldbeconfirmedbyfluoroscopy. CAUTION:Foroptimalproductperformance,donotinsertanyportionofthecuffintothevein. WARNING:Cardiacarrhythmiasmayresultiftheguidewireand/orstyletisallowedtotouchthewallsoftherightatrium. 9. Removetheguidewireandstyletwhileapplyingforwardpressureonthecathetersoitdoesnotwithdraw. CAUTION:Ensurethatthecatheterdoesnotmoveoutoftheveinwhileremovingtheinsertionstylet. 10. GotoD(CommonSteps) INSERTION TECHNIQUE (3) Sheathless Procedure2: Forsheathlessplacement,thecatheterispreferablyinsertedintotheinternaljugularvein.Forthesheathlessprocedure,thepatient should be placed in Trendelenburg position with the head turned to the opposite side of the entry site. 5. 6. Step2. 7. 8. Step3. C (INSERTION TECHNIQUE (1): PERCUTANEOUS PLACEMENT) 1. Unlock,remove,anddiscardstylet. CAUTION:Styletisintendedforuseoveraguidewiretoaidinplacement.Insertingthestyletintothevenotomywithouttracking over a guidewire could result in vessel damage including perforation. 2. Fillthecatheterlumenswithheparinizedsalinesolution. 3. Advancethedilatorsheathintroducerassemblyovertheexposedguidewireintothevessel. CAUTION:CareshouldbetakenNOTtoforcethedilatorsheathintroducerassemblyintothevesselduringinsertionasvessel damageincludingperforationcouldresult.Asreportedinliterature,leftsidedcatheterplacementmayprovideuniquechallenges duetotherightanglesformedbytheinnominateveinandattheleftbrachiocephalicjunctionwiththeSVC.5,8 WARNING:Cardiacarrhythmiasmayresultiftheguidewireisallowedtotouchthewallsoftherightatrium. 4. Withdrawthevesseldilatorandguidewire,leavingtheintroducersheathinplace. CAUTION:Careshouldbetakennottoadvancethesplitsheathtoofarintovesselasapotentialkinkwouldcreateanimpasseto the catheter. WARNING:Topreventairembolismand/orbloodloss,placethumbovertheexposedorificeofthesheathintroducer. 5. Removethumbandfeeddistalsectionofcatheterintothesheathintroducer.Advancethecathetertip.Cathetertipplacement,tip orientationandproperlengthselectionislefttothediscretionofthephysician.However,routinex-rayshouldalwaysfollowthe initialinsertiontoconfirmproperplacementofthecathetertipspriortouse.Therecommendedtiplocationisatthejunctionofthe superiorvenacava/rightatrium(SVC/RA)orinthemidrightatrium.6Alltipplacementsshouldbeconfirmedbyfluoroscopy. 6. Withthecatheteradvanced,peelawaythesheathbygrippingthe“T”handleandbreakingitapartwithadownwardandoutward motion to initiate separation and withdrawal of the sheath. CAUTION:Ensurethattheintroducersheathisonlytornexternally.Cathetermayneedtobefurtherpushedintothevesselas sheath is torn. CAUTION:Foroptimalproductperformance,donotinsertanyportionofthecuffintothevein. 7. D(CommonSteps). D (COMMON STEPS) 1. Confirmcatheterpatencybyreleasingclampandaspiratingbloodthrougheachlumen. 2. Flusheachlumenwith10mLsterilesalineusinga10mLorlargersyringe. WARNING:Toavoiddamagetovesselsandviscus,infusionpressuresshouldnotexceed25psi(172kPa).Theuseofa10mLor larger syringe is recommended because smaller syringes generate more pressure than larger syringes 3. Injectheparinsolutionintoeachlumeninamountsequaltotheprimingvolumesasprintedonthecatheterclamps.Besureto clamp each lumen immediately. WARNING:Failuretoclampextensionswhennotinusemayleadtoairembolism. 4. Foradditionalsecurity,suturetheentireentrysite,oruseaStatlock*CatheterStabilizationdevicetoanchorthecatheter. 5. Followyourhospitalprotocolfordressingchangeandexitsitecare.Allowalcohol-containingagents(e.g.,Chloraprep*solution)to air dry completely before dressing catheter. WARNING:AcetoneandPEG-containingointmentscancausefailureofthisdeviceandshouldnotbeusedwithpolyurethane catheters.Chlorhexidinepatchesorbacitracinzincointments(e.g.,Polysporin*ointment)arethepreferredalternative. 6. Verifythecathetertiplocationwithx-rayorfluoroscopy. 9. 10. GotoA(CommonSteps). GotoB(CommonSteps). SkipC(InsertionTechnique(1)PercutaneousPlacement). Sequentiallydilate(guidingdilatorsovertheguidewire),thevenouspuncturesitetoaccommodatethecatheter(dilatevesseltoat leastthesameFrenchsizeasthecatheter,andpreferablyto1.5Flarger). Afterremovingthedilator,keeptheguidewireinthevenoussystemwhileapplyingdigitalcompressionatthepuncturesiteto maintain hemostasis. Ifnotusingastylet,theproximalendoftheguidewiremustbeinsertedintothesmallvenousendholeof 6. thedistal-mosttip,andthreadedintotheendholeofthearterialtip,passingthroughthearteriallumenuntil itextendsoutthearterialLuer-lockconnector(red).Ifusingstylet,threadtheproximalendoftheguidewire throughthedistaltipofthestyletuntiltheguidewireextendsoutthestyletLuer-lockconnector. Tominimizetheriskofairembolism,clampthevenousextensionleg(indicatedbytheblueLuer-lock connector). Advancethecatheteroverthewire,untilthetipreachesthedesiredlocation.Notethatsomeresistancemaybeexperiencedwhen passing the catheter through the soft tissues, but this should subside once the catheter tip is intravascular. CAUTION:Foroptimalproductperformance,donotinsertanyportionofthecuffintothevein. WARNING:Cardiacarrhythmiasmayresultiftheguidewireand/orstyletisallowedtotouchthewallsoftherightatrium. Removetheguidewireandstylet(ifapplicable)whileapplyingforwardpressureonthecathetersoitdoesnotwithdraw. CAUTION:Ensurethatthecatheterdoesnotmoveoutoftheveinwhileremovingtheinsertionstylet. GotoD(CommonSteps). INSERTION TECHNIQUE (4) Femoral Vein Placement Procedure: Forfemoralplacement,thepatientshouldbepositionedsupine,andthecathetertipshouldbeinsertedtothejunctionoftheiliacvein and inferior vena cava3. WARNING: The risk of infection is increased with femoral vein insertion. Note:Cathetersgreaterthan40cmareintendedforfemoralveininsertion. 1. Assesstherightandleftfemoralareasforsuitabilityforcatheterplacement.Ultrasoundmaybehelpful. 2. Onthesamesideastheinsertionsite,thepatient’skneeshouldbeflexed,andthethighabductedwiththefootplacedacrossthe opposing leg. 3. Locatethefemoralvein,posterior/medialtothefemoralartery. 4. GotoA(CommonSteps). 5. GotoB(CommonSteps),directingtunnellaterallytodecreasetheriskofinfection.4 6. GotoC(InsertionTechnique(1)PercutaneousPlacement). 14.5 F Equistream* Catheter Venous and Arterial Pressures • 250 Optional:Placeapre-cutgauzedressingover theexitsite,fittingitsnuglyaroundthecatheter. Placea2in.x2in.(5cmx5cm)gauzeover thepre-cutgauzeandcatheter. 2. Applyacoverdressing,leavingtheextension legsexposed.Ifusingasterile,transparent, semipermeable dressing, the following is recommended: 19 cm Venous 150 19 cm Arterial 42 cm Arterial 100 50 0 -50 300 mL/min 350 mL/min 400 mL/min 450 mL/min 500 mL/min • As suggested by in vitro data, using a blood simulate approximating the viscosity of whole blood. Reverse Flow Rate vs Venous Pressures • -100 42 cm Straight Catheter Reverse Flow -150 300 mL/min 400 mL/min -200 140 mmHg 159 mmHg -250 16 F Equistream* XK Catheter Venous and Arterial Pressures • 250 42 cm Venous 200 2b.Viewingcathetersitethroughthedressingon theskinsothattheslitisoverthecatheterhub.Pressone side of dressing into place while holding the other side off the skin. 2c. Partiallyremovetheframeportionofthe dressing near the catheter hub which is already secured to the skin. 19 cm Venous 150 2a.Cuta1-2inch(3-5cm)slitintheshortside ofthedressingusingsterilescissors.Remove the backing sheet. 19 cm Arterial 42 cm Arterial 100 Pressures (mmHg) 42 cm Venous 200 Recommended Dressing Technique 1. Securethecathetertotheskinusingoneor two sterile tape strips. WARNING: Acetone and PEG-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments (e.g., Polysporin* ointment) are the preferred alternative. INSERTION TECHNIQUE (2) Surgical Cutdown Procedure: Thecathetermaybeinsertedintothesuperiorvenacavaviathesubclavianvein,externaljugularveinortheinternaljugularvein (standardoperatingroomprocedure).Forsurgicalcutdownprocedure,thepatientshouldbeplacedinTrendelenburgpositionwiththe head turned to the opposite side of the entry site. 1. 2. 3. 4. B (COMMON STEPS) 1. Ifusingstylet,unscrewthestylethubfromthearterialLuer-lockconnectorandretractstyletuntilitisno longer visible at the arterial lumen tip. CAUTION:Failuretoretractthestyletwheninsertingthetunnelerintothecathetertipcanresultindamage to the stylet. 2. Withatunneler,createasubcutaneoustunnelfromthecatheterexitsitetoemergeatthevenousentrysite. IfusingtheBard Access Systems, Inc.tunneler(seesteps1to3),attachthecathetertothetunnelerso thatthecatheter’svenoustipslidesoverthebarbedconnectionandrestsadjacenttothesheathstop.This allowsthecathetertobethreadedthroughthetissueasthetunneliscreated.Slidethesheathfoundonthe tunneleroverthevenoustip/tunnelerconnectionuntilitstops.Inaddition,ensuretheopenendofsheathis covering the arterial tip. This will reduce the drag on the arterial tip in the skin tunnel and secure the catheter tothetunneler.(Afterpositioningcuff,tunnelercanberemovedbyslidingsheathawayfromthecatheterand pullingtunnelerfromvenoustip.)Thecathetershouldnotbeforcedthroughthetunnel. 3. Positionthewhiteretentioncuffapproximatelymidwaybetweentheskinexitsiteandthevenousentrysite, 3cmminimum,fromthevenousentrysite.Detachtunnelerfromcatheter. 4. Ifusingstylet,pushthestyletbackintocatheterandtightenstylethubontoarterialcatheterLuer-lock connector.Threadstylettipintoproximalsideofthevenousendholeandallowstylettiptoprotrudefromtip of catheter. 2d.Overlaptheunsecuredsideofthedressing slightly over the secured side to seal dressing undercatheterhub.Carefullyremovethe framefromthedressingwhilefirmly smoothingdowntheedges.Smoothdownthe entire dressing. Pressures (mmHg) 50 0 -50 -100 -150 -200 -250 300 mL/min 350 mL/min 400 mL/min 450 mL/min 500 mL/min • As suggested by in vitro data, using a blood simulate approximating the viscosity of whole blood. Reverse Flow Rate vs Venous Pressures • 42 cm Straight Catheter - Reverse Flow 300 mL/min 97 mmHg 500 mL/min 117 mmHg CARE AND MAINTENANCE The care and and maintenance of the catheter requires well trained, skilled personnel following a detailed protocol. The protocol should include a directive that the catheter is not to be used for any purpose other than the prescribed therapy. Accessing Catheter, Cap Changes, Dressing Changes6 • Experienced personnel • Use aseptic technique • Proper hand hygiene • Clean gloves to access catheter and remove dressing and sterile gloves for dressing changes • Surgical mask (1 for the patient and 1 for the healthcare professional) • Catheter exit site should be examined for signs of infection and dressings should be changed at each dialysis treatment. • Catheter Luer-lock connectors with end caps attached should be soaked for 3 to 5 minutes in povidone iodine and then allowed to dry before separation. • Carefully remove the dressing and inspect the exit site for inflammation, swelling and tenderness. Notify physician immediately if signs of infection are present. Exit Site Cleaning11 • Use aseptic technique (as outlined above). • Clean the exit site at each dialysis treatment with chlorhexidine gluconate unless contraindicated. Apply antiseptic per manufacturer’s recommendations. Allow to air dry completely. • Cover the exit site with sterile, transparent, semipermeable dressing or per hospital protocol. The Equistream* and Equistream* XK catheters have two separate free floating tips, separated at a fixed point. Recommended Cleaning Solutions Catheter Luer-lock Connectors/End Caps: • Povidone iodine (allow connectors/end caps to soak for 3 to 5 minutes) 8 WARNING: Alcohol should not be used to lock, soak or declot polyurethane Dialysis Catheters because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure. Hand cleaner solutions are not intended to be used for disinfecting our dialysis catheter Luer-lock connectors. Exit Site: • Chlorhexidine gluconate 2% solution (preferred) 6, 10, 11, 12, 13 • Chlorhexidine gluconate 4% solution • Dilute aqueous sodium hypochlorite • 0.55% sodium hypochlorite solution • Povidone iodine • Hydrogen peroxide • Chlorhexidine patches • Bacitracin zinc ointments in petrolatum bases WARNING: Acetone and PEG-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments (e.g., Polysporin* ointment) are the preferred alternative. INSTRUCTIONS FOR USE For Equistream* Straight and Alphacurve* Configuration Catheters ___________________________________________________________________________________________________________ DESCRIPTION The Equistream* and Equistream* XK catheters are made of radiopaque polyurethane, and allow for flow rates as high as 500 ml/min. The catheter shaft is divided internally into two separate lumens by a septum allowing hemodialysis without the use of a “single needle” system. The catheter comes with a white retention cuff for tissue ingrowth to anchor the catheter. INDICATIONS FOR USE The Equistream* and Equistream* XK long-term hemodialysis catheters are indicated for use in attaining short-term or long-term vascular access for hemodialysis, hemoperfusion or apheresis therapy. Access is attained via the internal jugular vein, external jugular vein, subclavian vein, or femoral vein. Catheters longer than 40 cm are intended for femoral vein insertion. CONTRAINDICATION This device is contraindicated for patients exhibiting severe, uncontrolled thrombocytopenia or coagulopathy. WARNINGS Subclavian Vein CATHETER REMOVAL Evaluate the catheter routinely and promptly remove any nonessential catheter11 per physician’s orders. The white retention cuff facilitates tissue in-growth. The catheter must be surgically removed. Free the cuff from the tissue and pull the catheter gently and smoothly. After removing the catheter, apply manual pressure to the puncture site for 10-15 minutes until no signs of bleeding are present. Then apply sterile, transparent, semipermeable dressing or dressing per hospital protocol for a minimum of 8 hours. Follow hospital protocol regarding bedrest after catheter removal. DISPOSAL After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and all applicable local, state and federal laws and regulations. TROUBLESHOOTING PATIENT WITH FEVER Patient with fever and chills following the procedure may be indicative of catheter-related bacteremia. If bacteremia is present, removal of the catheter may be indicated. INSUFFICIENT FLOW Excessive force must not be used to flush an obstructed lumen. Insufficient blood flow may be caused by an occluded tip resulting from a clot or by contacting the wall of the vein. If manipulation of the catheter or reversing arterial and venous lines does not help, then the physician may attempt to dissolve the clot with a thrombolytic agent (e.g., TPA, Cathflo* Activase* thrombolytic). Physician discretion advised. CATHETER EXCHANGE Do not routinely replace dialysis catheters to prevent catheter-related infections13. It may become necessary to exchange the indwelling catheter due to a persistent rise in pressures or decrease of flow rates which cannot be rectified through troubleshooting. Catheter exchanges should be performed under strict aseptic conditions in which the physician should wear a cap, mask, sterile gown, sterile gloves, and use a large sterile drape to cover the patient. REFERENCES: Aitken, D.R. and Minton, J.P. “The Pinch-Off Sign: A Warning of Impending Problems with Permanent Subclavian Catheters”, American Journal of Surgery, Vol. 148, Nov. 1984, pp.633-638. Patel, A, et al “Sheathless Technique of Ash Split Catheter Insertion.” J Vasc Interv Radiol 2001; 12:376-378. 3 Zaleski, GX, et al. “Experience with Tunneled Femoral Hemodialysis Catheters.” Am J Roentgenol. 1999 Feb; 172(2):493-6. 4 Rogers, P.R. et al “Pocket Radiologist Interventional Top 100 Procedures”, Amirsys, 1st Ed., 2003. 5 Mickley, V., “Central venous catheters: many questions: few answers”, Nephrol Dial Transplant, (2002) 17:1368-1373. 6 National Kidney Foundation K/DOQI Guidelines, 2006. 7 Sulek, CA., Blas, ML., Lobato, EB, “A randomized study of left versus right internal jugular vein cannulation in adults.” J Clin Anesth. 2000 Mar;12(2):142-5 8 Tan, P.L., Gibson, M., “Central Venous Catheters: the role of radiology”, Clin Rad. 2006, 61:13-22 9 Octavio, Bella, Colemenares, Garcia, and Flores; “Right Verses Left Internal Vein Catheterization for Hemodialysis: Complications and Impact on Ipsilateral Access Creation”; Artifical Organs; 2004, 28(8):728-733. 10 The Institute for Healthcare Improvement, “How-to-Guide: Prevent Central Line Infections,” 2006. 11 The Joint Commission Hospital Accreditation Organization, National Patient Safety Goals, 2009. 12 Center for Disease Control and Prevention, “Guidelines for the Prevention of Intravascular Catheter-Related Infections,” Morbidity and Mortality Weekly Report, Aug. 9, 2002, 51(RR-10), 1-32. 13 The Society for Healthcare Epidemiology of America, “Strategies to Prevent Central Line-Associated Bloodstream Infections in Acute Care Hospitals,” Infection Control and Hospital Epidemiology, Oct. 2008, 29(S1): S22-S30. 1 2 Other references available upon request. ___________________________________________________________________________________________________________ An issued or revision date for these instructions is included for the users information. In the event two years have elapsed between this date and product use, the user should contact Bard Access Systems, Inc. to see if additional product information is available. Revision date: October, 2010. *Bard, Alphacurve, Equistream, and StatLock are trademarks and/or registered trademarks of C. R. Bard, Inc. All other trademarks are the property of their respective owners. © 2010 C. R. Bard, Inc. All rights reserved. 0727467 1011R Bard Access Systems, Inc. Salt Lake City, UT 84116 U.S.A. 1-801-522-5000 Customer Service: 800-545-0890 Clinical Information: 800-443-3385 www.bardaccess.com Vertebra Internal Jugular Vein Superior Vena Cava Clavicle Axillary Vein POST DIALYSIS Use aseptic technique (as outlined above). 1. Flush arterial and venous lumens with a minimum of 10 mL of sterile saline. WARNING: To avoid damage to vessels and viscus, infusion pressures must not exceed 25 psi (172 kPa). The use of a 10 mL or larger syringe is recommended because smaller syringes generate more pressure than larger syringes. 2. Inject heparin solution into both the arterial and venous lumens of the catheter. The appropriate heparin solution concentration and flushing frequency should be based on hospital protocol. Heparin solution of 1,000 to 5,000 units/mL has been found to be effective for maintaining the patency of hemodialysis and apheresis catheters. When injecting heparin solution, inject quickly and clamp extension while under positive pressure. Heparin solution volume to lock each lumen must be equal to the priming volume of each lumen. Priming volumes are marked on each lumen. 3. Clean catheter Luer-lock connectors per hospital protocol. Attach sterile end caps to both the arterial and the venous clamping extension pieces. WARNING: To prevent systemic heparinization of the patient, the heparin solution must be aspirated out of both lumens immediately prior to using the catheter. In most instances, no further heparin solution injection is necessary for 48-72 hours, provided the catheter has not been aspirated or flushed. First Rib Pinch-off Area Sternum Infraclavicular Fossa WARNING: Percutaneous insertion of the catheter should be made into the axillary-subclavian vein at the junction of the outer and mid-thirds of the clavicle lateral to the thoracic outlet. The catheter should not be inserted into the subclavian vein medially, because such placement can lead to compression of the catheter between the first rib and clavicle and can lead to damage or fracture and embolization of the catheter.1 Fluoroscopic or radiographic confirmation of catheter tip placement should be helpful in demonstrating that the catheter is not being pinched by the first rib and clavicle.1 • Alcohol or alcohol-containing antiseptics (such as chlorhexidine) may be used to clean the catheter/skin site; however, care should be taken to avoid prolonged or excessive contact with the solution(s). Solutions should be allowed to completely dry before applying dressing. • Acetone and Polyethylene Glycol (PEG)-containing ointments can cause failure of this device and should not be used with polyurethane catheters. Chlorhexidine patches or bacitracin zinc ointments (e.g., Polysporin* ointment) are the preferred alternative. • Follow Universal Precautions when inserting and maintaining this device. • Cardiac arrhythmias may result if the guidewire and/or stylet touches the walls of the right atrium. Use cardiac rhythm monitoring to detect arrhythmias. • Close all clamps only in the center of the extension legs. Extensions may develop cuts or tears if subjected to excessive pulling or contact with rough edges. Repeated clamping near or on the Luer-lock connectors may cause tubing fatigue and possible disconnection. • Catheters should be implanted carefully. • Any sharp or acute angles that could compromise the opening of the catheter lumens need to be avoided. • To prevent air embolism and/or blood loss put patient in Trendelenburg position and always place thumb over the exposed orifice of the sheath introducer. • To avoid damage to vessels and viscus, infusion pressures should not exceed 25 psi (172 kPa). The use of a 10 mL or larger syringe is recommended because smaller syringes generate more pressure than larger syringes. Note: A three pound (13.3 Newton) force on the plunger of a 3 mL syringe generates pressure in excess of 30 psi (206 kPa) whereas the same three pound (13.3 Newton) force on the plunger of a 10 mL syringe generates less than 15 psi (103 kPa) of pressure. • Accessories and components used in conjunction with this catheter should incorporate Luer-lock adapters. • The heparin solution must be aspirated out of both lumens immediately prior to using the catheter to prevent systemic heparinization of the patient. • Failure to clamp extensions when not in use may lead to air embolism. • In the rare event of a leak, the catheter should be clamped immediately. Necessary remedial action must be taken prior to resuming dialysis or infusion procedure. • The risk of infection is increased with femoral vein insertion. • Do not resterilize the catheter or components by any method. The manufacturer will not be liable for any damages caused by reuse of the catheter or accessories. • Cannulation of the left internal jugular vein was reportedly associated with a higher incidence of complications compared to catheter placement in the right internal jugular vein.7 • Alcohol should not be used to lock, soak or declot polyurethane Dialysis Catheters because alcohol is known to degrade polyurethane catheters over time with repeated and prolonged exposure. • Intended for Single Use. DO NOT REUSE. Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient. CAUTIONS • Repeated over tightening of blood lines, syringes and caps will reduce connector life and could lead to potential connector failure. In case of damage, clamp the catheter between the patient and the damaged area with a smooth-edged, atraumatic clamp. • Sterile and non-pyrogenic only if packaging is not opened, damaged or broken. • Read the instructions for use carefully before using this device. • CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. • Left sided placement in particular, may provide unique challenges due to the right angles formed by the innominate vein and at the left brachiocephalic junction with the SVC.5,8 • Care should be taken NOT to force the dilator sheath introducer assembly into the vessel during insertion as vessel damage including perforation could result. • Stylet is intended for use over a guidewire to aid in placement. Inserting the stylet into the venotomy without tracking over a guidewire could result in vessel damage including perforation. • Failure to retract the stylet when inserting the tunneler into the catheter tip can result in damage to the stylet. • Ensure that the catheter does not move out of the vein while removing the insertion stylet. • Care should be taken not to advance the split sheath too far into vessel as a potential kink would create an impasse to the catheter. • Ensure that the introducer sheath is only torn externally. Catheter may need to be further pushed into the vessel as sheath is torn. • For optimal product performance, do not insert any portion of the cuff into the vein. • If the microintroducer guidewire must be withdrawn while the needle is inserted, remove both the needle and wire as a unit to prevent the needle from damaging or shearing the guidewire. • Before attempting the insertion of Equistream* catheters, ensure that you are familiar with the complications listed below and their emergency treatment should any of them occur. • The complications listed below as well as other complications are well documented in medical literature and should be carefully considered before placing the catheter. Placement and care of Equistream* catheters should be performed by persons knowledgeable of the risks involved and qualified in the procedures. POSSIBLE COMPLICATIONS The use of an indwelling central venous catheter provides an important means of venous access for critically ill patients; however, the potential exists for serious complications including the following: •Air Embolism •Arterial Puncture •Bleeding •Brachial Plexus Injury •Cardiac Arrhythmia •Cardiac Tamponade •Catheter or Cuff Erosion Through the Skin •Catheter Embolism •Catheter Occlusion •Catheter Occlusion, Damage or Breakage due to Compression Between the Clavicle and First Rib1 • Catheter-related Sepsis •Endocarditis •Exit Site Infection •Exit Site Necrosis •Extravasation •Fibrin Sheath Formation •Hematoma •Hemomediastinum •Hemothorax •Hydrothorax •Inflammation, Necrosis or scarring of skin over implant area •Intolerance Reaction to Implanted Device •Laceration of Vessels or Viscus •Perforation of Vessels or Viscus • Pneumothorax •Thoracic Duct Injury •Thromboembolism •Venous Stenosis •Venous Thrombosis •Ventricular Thrombosis •Vessel Erosion •Risks Normally Associated with Local and General Anesthesia, Surgery, and Post-Operative Recovery INSERTION TECHNIQUE (1) Percutaneous Placement Procedure of the Equistream* catheter with cuff using the Bard Access Systems, Inc. split sheath introducer: